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Australian prescribers’ views on biologicals naming and substitution

Biosimilars/Research | Posted 03/11/2017 0 Post your comment

In a survey of 160 prescribers of biologicals in Australia, over three quarters agreed that the country’s Therapeutic Goods Administration (TGA) should insist on distinct non-proprietary scientific names for all biosimilars and reference products. The results of the survey were published just as TGA launched a public consultation on proposals for potential biological naming systems. A clear majority (98%) of prescribers who took part in the survey, run by the Alliance for Safe Biologic Medicines (ASBM), said they currently used either brand name or non-proprietary scientific names for recording and prescribing biosimilars and reference products [1]. Most (61%) wanted TGA to play a major role in naming biosimilars.

The same proportion (61%) of respondents believed TGA should be responsible for recommendations on pharmacy-level substitution, while only a third (33%) thought that Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) should be responsible. The PBAC has indicated it will consider pharmacy-level substitution of biosimilars for reference biological medicines on a ‘case-by-case basis’.

According to the results of the Australian prescribers’ survey, the reporting of biosimilars use via brand name and batch number varied between respondents. Brand name and non-proprietary scientific name were used with about equal frequency when recording reference biologicals and biosimilars in patient records (39% and 38%, respectively). Just over half of respondents (53%) said they rarely or never included batch numbers when reporting adverse events.

The announcement that TGA has started gathering feedback on proposals for potential biological naming systems [2] reflects a move to bring Australia in line with international practice in this area. This will not be straightforward, however, since TGA recognizes the significantly different approaches now adopted by Europe [3, 4] and the US [5].

In the European Union, both the brand name and International Nonproprietary Name (INN) are used to identify the specific biological product, whether it is a reference biological or a biosimilar. In the US, the Food and Drug Administration’s (FDA) approach is to require biosimilars and their reference products to have distinguishable non-proprietary names. FDA approach is to assign a random, meaningless suffix containing four letters to all biologicals to facilitate pharmacovigilance.

While the responses of prescribers in the Australian survey did vary, it was generally agreed that biosimilars should be distinguished from originators with either the same non-proprietary scientific name and a differing prefix or suffix, or with a completely unique name. On substitution, nearly all prescribers thought that they and their patients should decide which biological is dispensed and that they should be notified of any substitution by the pharmacist.

Editor’s comment
This article for GaBI Online is a summary of the full manuscript published in GaBI Journal.

If you would like to receive a copy of the GaBI Journal manuscript [1], please send us an email.

Readers interested to learn more about naming and labelling of biologicals are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:

Tell me the whole story: the role of product labelling in building user confidence in biosimilars in Europe

The challenges of nomenclature – INN, biosimilars and biological qualifiers

If you are interested in contributing a research or perspective paper in a similar area to the GaBI Journal, please send us your submission here.

FDA issues final guidance on naming biologicals

References
1. Murby SP, Reilly MS. A survey of Australian prescribers’ views on the naming and substitution of biologicals. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(3):107-12. doi:10.5639/gabij.2017.0603.022
2. GaBI Online - Generics and Biosimilars Initiative. Australia’s TGA consults on naming of biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 3]. Available from: www.gabionline.net/Biosimilars/General/Australia-s-TGA-consults-on-naming-of-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. Arguments for same INN for biosimilars presented at WHO meeting [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 3]. Available from: www.gabionline.net/Biosimilars/General/Arguments-for-same-INN-for-biosimilars-presented-at-WHO-meeting
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar naming conventions around the world [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 3]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilar-naming-conventions-around-the-world
5. GaBI Online - Generics and Biosimilars Initiative. FDA issues final guidance on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 3]. Available from: www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-naming-biologicals

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